2022 ISPE May Online Live Training
Deep Dive into Pharma Training Courses
Gain solutions to your company's immediate goals to lower production costs, improve process efficiency, increase production quality, and meet regulatory requirements.
- Real World Practice: Courses present exercises that use current problems and situations common to the industry.
- Experienced Instructors: Subject matter experts and top leaders in the pharmaceutical industry who have years of experience in their field of study.
- Global Training to Fit Your Needs: With eLearning
Aseptic Processing & Annex 1
2 - 3 May 2022
This course will focus on aseptic processing and quality management around the most important pharmaceutical technology.
Instructor
Pharma Water Generation
9 - 10 May 2022
This online course has been substantially updated to feature the guiding principles of the ISPE Baseline Guide: Water and Steam Systems (Second Edition) with particular emphasis placed upon the new chapters for microbial control and laboratory water as well as key design philosophies.
Instructor
Science and Risk-based Commissioning and Qualification
16 - 19 May 2022
Through interactive workshops, this course will explain and apply the science and risk-based approach to integrated lifecycle Commissioning & Qualification by conducting verification of systems, equipment and facilities in accordance with the recently issued 2nd Edition Guide, ICH documents Q8 (R2), Q9, and Q10, current Regulatory Guidance, industry best practices, and ASTM E2500.
Instructor
Biopharmaceuticals: Introduction to Large Molecule Therapeutics
19 - 20 May 2022
The course will cover process development, formulation, cell banking, manufacturing of drug substance, drug product and analytics. The need for Quality by Design in all aspects of biopharmaceutical development will be emphasized.
Instructor
Biotechnology Manufacturing Facility Design
23 - 24 May 2021
The course includes a review of biopharmaceutical manufacturing facility design and regulatory issues important in the US and Europe that involve industry trends and changing regulatory policy. Participants will discuss current case studies on a wide array of facility topics, and complete class exercises that involve developing facility scope of work and deliverables to meet corporate economic goals and regulatory requirements.
Instructor
GAMP® Data Integrity 21 CFR Part 11
31 May - 3 June 2022
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
Instructors
Winnie Cappucci
Retired